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OpenTrials
Completed

NCT Number: NCT05222737

Quantitation of Bacteria Associated With Severe Periodontitis by Real -Time PCR Following Application of Diode Laser

1. Primary objective To measure the gingival crevicular levels of A.actinomycetemcomitans and P.gingivalis after intra-pocket application of diode laser in severe periodontitis (stage 3 grade C) patients. 2. Secondary objective To compare the levels of the same microorganisms as in cases of diode laser therapy to those after conventional treatment with systemic antibiotic administration in severe periodontitis (stage 3 grade C) patients. 3. to measure clinical parameters probing depth,attachment loss and mobility grade

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Key information

Conditions

Periodontal Pocket Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

15 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Amira Hafez

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of both sexes having severe periodontitis (stage 3 grade C) with interdental clinical attachment loss (CAL) ≥ 5.
  • Patients' age between 15 and 35 years old with rapid bone loss showed by radiograph.
  • Systemically healthy patients.
  • Radiographic bone loss extending to middle or apical third of root.
  • Probing depth (PD) ≥ 6 mm.

Exclusion criteria

  • Use of antibiotics during the last 3 months.
  • Pregnancy.
  • Any systemic condition that might affect the study.
  • Use of mouthwash containing antimicrobials during the previous 3 weeks.
  • Smoking.

Treatment and study plan

medency diode laser

Device

intra pocket application of diode laser

spirazole forte

Drug

adminstration of spirazole forte with a dose 17 mg per kg

Primary outcomes

  1. Quantitation of Aggrecatibacter .actinomycetemcomitans and porphyromonas gingivalis bacteria

    Time frame: baseline

    To measure the gingival crevicular levels of A.actinomycetemcomitans and P.gingivalis after intra-pocket application of diode laser in severe periodontitis(stage 3 grade C) patients

Secondary outcomes

  1. comparing levels of bacteria between test and control groups

    Time frame: baseline

    To compare the levels of the same microorganisms as in cases of diode laser therapy to those after conventional treatment with systemic antibiotic administration in severe periodontitis ( stage 3 grade C) patients.

Other outcomes

  1. Probing depth(PPD)

    Time frame: Baseline ,one month and 3 months

    Measure PPD at baseline and after treatment

  2. Clinical Attachment loss(CAL)

    Time frame: Baseline ,one month and 3 months

    Measure CAL at baseline and after treatment

  3. Mobility grade

    Time frame: Baseline ,one month and 3 months

    Measure mobility grade at baseline and after treatment

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Quantitave Assessment of Aggregatibacter Actinomycetemcomitans and Porphyromonas Gingivalis by Real -Time PCR Following Application of Diode Laser in Severe Periodontitis (A RANDIOMIZED CONTROLLED CLINICAL TRIAL)

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 3, 2022
Registry last updated
Jul 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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